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1.
Crit Care Resusc ; 22(2): 110-118, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32389103

RESUMO

Comparative effectiveness research can help guide the use of common, routine medical practices. However, to be safe and informative, such trials must include at least one treatment arm that accurately portrays current practices. While comparative effectiveness research is widely perceived as safe and to involve no or only minimal risks, these assumptions may not hold true if unrecognised deviations from usual care exist in one or more study arms. For critically ill subjects in particular, such practice deviations may increase the risk of death or injury and undermine safety monitoring. Furthermore, unrecognised unusual care seems likely to corrupt informed consent documents, with underappreciated risks shrouded under the reassuring "comparative effectiveness" research label. At present, oversight measures are inadequate to ensure that research subjects enrolled in comparative effectiveness trials are actually receiving usual and not unusual care. Oversight by governmental and non-governmental entities with appropriate expertise, empowered to ensure that current clinical practice has been properly represented, could help prevent occurrences in clinical trials of unusual care masquerading as usual care.


Assuntos
Pesquisa Comparativa da Efetividade , Estado Terminal , Sujeitos da Pesquisa , Ética em Pesquisa , Humanos , Projetos de Pesquisa
3.
Ágora (Rio J. Online) ; 23(1): 12-20, Jan.-Apr. 2020. graf
Artigo em Português | LILACS, Index Psicologia - Periódicos técnico-científicos | ID: biblio-1059218

RESUMO

RESUMO: Neste artigo, são discutidas possibilidades de tecitura entre os pressupostos da Reforma Psiquiátrica Brasileira e a lógica diagnóstica psicanalítica. Veicula-se brevemente a história desse importante movimento. Posteriormente, são apresentados elementos do diagnóstico em psicanálise, enfatizando o lugar do sujeito e sua dimensão irredutível frente aos discursos sociais hegemônicos. Demonstra-se o quanto a clínica psicanalítica coincide com um processo de "crítica da ideologia", levantando questões da lógica diagnóstica predominante nos serviços substitutivos aos manicômios, de modo que são assinaladas as convergências entre o trabalho psicossocial e a clínica. Por fim, destaca-se que a psicanálise se constitui como uma forma específica de oferecer escuta, visando efeitos de desalienação e reconhecimento da diferença.


Abstract: In this article, are discussed possibilities of interlacing between the presuppositions of the Brazilian Psychiatric Reform and the psychoanalytical diagnostic logic. The history of this important movement is briefly conveyed. Posteriorly, elements of the diagnosis in psychoanalysis are presented, highlighting the place of the subject and its irreducible dimension in front of the hegemonic social discourses. It is demonstrated how much the psychoanalytic clinic coincides with a process of "critique of ideology", raising questions on the diagnostic logic currently prevalent in the substitute services to asylums, so that the convergences between the psychosocial and the clinical work are pointed. Finally, it is highlighted that the psychoanalysis constitutes a specific form of listening, aiming at the effects of de-alienation and recognition of difference.


Assuntos
Psicanálise , Sujeitos da Pesquisa
4.
G Ital Cardiol (Rome) ; 21(4): 309-314, 2020 Apr.
Artigo em Italiano | MEDLINE | ID: mdl-32202565

RESUMO

BACKGROUND: The request for informed consent to join a clinical trial often creates mistrust and hesitation in the patient who should be enrolled. In our study, we evaluated the reasons for refusing to participate in a clinical trial. METHODS: In the last 10 years of cardiovascular clinical research, we asked an informed consent to 2586 patients for intervention studies. Overall, 59% agreed to join clinical trials, 40% refused. The 1% initially accepted and then withdrew the consent. Those who refused were more frequently women, relatively younger (mean age 62 ± 5 vs 74 ± 9 years) and had a higher level of education and income. We asked all these patients who refused to answer a brief questionnaire about the reasons for rejection. RESULTS: Of 1031 patients, 629 (61%), accepted to answer the interview; 176 (28%) answered they refused on relatives', friends' or other doctors' advices, or after Internet searches; 157 (25%) answered they did not agree about how the trials were carried out (double-blind control procedure, use of placebo); 126 (20%) did not trust official medicine; 63 (10%) could not guarantee their presence at the follow-up visits; 69 (11%) did not want to undergo additional medical examinations; 31 (5%) had previous bad research experiences (feeling like a guinea pig); 7 (about 1%) refused for other reasons. CONCLUSIONS: Recruitment into clinical research studies is still a major challenge. Patients, due to a prevailing humanistic culture, are not fully aware of the importance of participation in clinical research, which is sometimes considered as exclusive economic or prestige interest. In our experience, people who refused participation in the trials were younger, with a high level of education and income, more frequently women. The researcher's task is to motivate the patient by emphasizing that participating in a study means being the actors of a treatment choice and that one is a guinea pig when taking untested therapies.


Assuntos
Ensaios Clínicos como Assunto , Consentimento Livre e Esclarecido , Participação do Paciente , Adulto , Tomada de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Participação do Paciente/psicologia , Seleção de Pacientes , Sujeitos da Pesquisa , Inquéritos e Questionários , Confiança
5.
Bull Cancer ; 107(3): 333-343, 2020 Mar.
Artigo em Francês | MEDLINE | ID: mdl-32037013

RESUMO

INTRODUCTION: Health researchers often face difficulties related to participants' recruitment for their research. However, a new strategy emerges: offering patients-but also citizens who are not ill-the possibility to volunteer as participants to hasten research processes. The French platform "Seintinelles" aims to fulfill this goal and bring together citizens who volunteered to participate to cancer related research. The "Seintinelles Barometer" aims to describe these volunteers' profile. METHODS: The Seintinelles Barometer data were collected through a web-based auto-questionnaire proposed to the "Seintinelles" members from June 2017 to November 2018. RESULTS: The sample presents a high level of overrepresentation of women. Participants are characterized by a high level of education. About a third of the participants had suffered from cancer. Two profile of volunteers emerged: the « patients ¼ and the « supportive citizens ¼. DISCUSSION: The Seintinelles Barometer participants manifest a strong wish to be involved in cancer related research. Therefore, this platform seems to be a promising tool for the development of community-based research in the field of cancer.


Assuntos
Escolaridade , Neoplasias , Desenvolvimento de Programas , Sujeitos da Pesquisa , Adulto , Fatores Etários , Saúde da Família , Feminino , França , Voluntários Saudáveis/educação , Voluntários Saudáveis/psicologia , Voluntários Saudáveis/estatística & dados numéricos , Humanos , Masculino , Estado Civil/estatística & dados numéricos , Pessoa de Meia-Idade , Motivação , Neoplasias/epidemiologia , Ocupações/estatística & dados numéricos , Seleção de Pacientes , Densidade Demográfica , Sujeitos da Pesquisa/educação , Sujeitos da Pesquisa/psicologia , Sujeitos da Pesquisa/estatística & dados numéricos , Fatores Sexuais , Inquéritos e Questionários
8.
BMC Health Serv Res ; 20(1): 25, 2020 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-31914994

RESUMO

BACKGROUND: Limited attention has been paid to adolescents and young adults' (AYA's) experiences in the aftermath of a cancer diagnosis, despite this being a time when potentially life-changing decisions are made. We explored AYA's and caregivers' experiences of, and views about, making treatment and trial participation decisions following a cancer diagnosis, in order to understand, and help facilitate, informed treatment decision-making in this age group. METHODS: Interviews were undertaken with 18 AYA diagnosed, or re-diagnosed, with cancer when aged 16-24 years, and 15 parents/caregivers. Analysis focused on the identification and description of explanatory themes. RESULTS: Most AYA described being extremely unwell by the time of diagnosis and, consequently, experiencing difficulties processing the news. Distress and acceleration in clinical activity following diagnosis could further impede the absorption of treatment-relevant information. After referral to a specialist cancer unit, many AYA described quickly transitioning to a calm and pragmatic mind-set, and wanting to commence treatment at the earliest opportunity. Most reported seeing information about short-term side-effects of treatment as having limited relevance to their recovery-focused outlook at that time. AYA seldom indicated wanting to make choices about front-line treatment, with most preferring to defer decisions to health professionals. Even when charged with decisions about trial participation, AYA reported welcoming a strong health professional steer. Parents/caregivers attempted to compensate for AYA's limited engagement with treatment-relevant information. However, in seeking to ensure AYA received the best treatment, these individuals had conflicting priorities and information needs. CONCLUSION: Our study highlights the challenging context in which AYA are confronted with decisions about front-line treatment, and reveals how their responses make it hard to ensure their decisions are fully informed. It raises questions about the direct value, to AYA, of approaches that aim to promote decision-making by improving understanding and recall of information, though such approaches may be of value to caregivers. In seeking to improve information-giving and involvement in treatment-related decision-making at diagnosis, care should be taken not to delegitimize the preference of many AYA for a directive approach from trusted clinicians.


Assuntos
Cuidadores/psicologia , Tomada de Decisões , Neoplasias/terapia , Participação do Paciente/psicologia , Sujeitos da Pesquisa/psicologia , Adolescente , Ensaios Clínicos como Assunto , Feminino , Humanos , Masculino , Neoplasias/diagnóstico , Pesquisa Qualitativa , Adulto Jovem
11.
J Stroke Cerebrovasc Dis ; 29(1): 104466, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31734125

RESUMO

BACKGROUND: Medical mistrust influences patients' treatment seeking, adherence, health behaviors, and minority participation in research studies. However, medical mistrust remains understudied within neurological diseases like stroke despite disproportionately affecting minority populations. OBJECTIVE: This study examines the relationship of medical mistrust with stroke knowledge among Black, Latino, Korean, and Chinese-Americans. METHODS: Subjects greater than 60 years were enrolled from senior centers to test a culturally-tailored educational curriculum around stroke risk reduction in a randomized controlled trial. A Trust Physician Scale and a modified Trust of Medical Researchers Scale measured medical mistrust. The Stroke Action Test instrument measured stroke knowledge, focusing on intent to call 911 appropriately when presented with stroke symptoms. RESULTS: Of 225 subjects, 69.5% were female (n = 157) with an average age of 73.7 years (standard deviation 6.7). Blacks had highest trust scores of physicians relative to Latino/a, Korean or Chinese subjects (P< .05). In multivariable analysis, decreased stroke knowledge was associated with decreased researcher trust at baseline (<.05), but not physician trust, when controlling for covariates. Among Latino/a, Korean, and Chinese groups, mainstream acculturation reduced the association between researcher trust and stroke knowledge. A mediation model showed no evidence of physician trust mediating researcher trust. CONCLUSIONS: Among minority seniors participating in a randomized controlled trial, decreased trust of researchers, not physicians, was associated with low baseline knowledge of stroke symptoms. Those least acculturated to US culture may be a particular focus for trust building intervention. Future studies should examine whether researcher mistrust is disproportionately preventing those with the largest knowledge gaps from participating in trials.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde/etnologia , Grupos Minoritários/psicologia , Educação de Pacientes como Assunto/métodos , Serviços Preventivos de Saúde , Relações Profissional-Paciente , Pesquisadores/psicologia , Sujeitos da Pesquisa/psicologia , Acidente Vascular Cerebral/prevenção & controle , Confiança , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Envelhecimento/etnologia , Envelhecimento/psicologia , Atitude do Pessoal de Saúde , Estudos Transversais , Características Culturais , Assistência à Saúde Culturalmente Competente/etnologia , Currículo , Feminino , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etnologia , Acidente Vascular Cerebral/psicologia
12.
J Abnorm Psychol ; 129(1): 49-55, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31868387

RESUMO

Clinical psychological research studies often require individuals with specific characteristics. The Internet can be used to recruit broadly, enabling the recruitment of rare groups such as people with specific psychological disorders. However, Internet-based research relies on participant self-report to determine eligibility, and thus, data quality depends on participant honesty. For those rare groups, even low levels of participant dishonesty can lead to a substantial proportion of fraudulent survey responses, and all studies will include careless respondents who do not pay attention to questions, do not understand them, or provide intentionally wrong responses. Poor-quality responses should be thought of as categorically different from high-quality responses. Including these responses will lead to the overestimation of the prevalence of rare groups and incorrect estimates of scale reliability, means, and correlations between constructs. We demonstrate that for these reasons, including poor-quality responses-which are usually positively skewed-will lead to several data-quality problems including spurious associations between measures. We provide recommendations about how to ensure that fraudulent participants are detected and excluded from self-report research studies. (PsycINFO Database Record (c) 2019 APA, all rights reserved).


Assuntos
Fraude , Sujeitos da Pesquisa , Pesquisa , Humanos , Reprodutibilidade dos Testes , Autorrelato , Inquéritos e Questionários
13.
Anesthesiology ; 132(1): 44-54, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31789635

RESUMO

There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.This article examines whether international ethical guidelines and the policy frameworks in three countries-the United States, England, and Australia-permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Sujeitos da Pesquisa/legislação & jurisprudência , Austrália , Inglaterra , Humanos , Internacionalidade , Risco , Estados Unidos
15.
Ann Vasc Surg ; 62: 406-411, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31491479

RESUMO

BACKGROUND: Although randomized controlled trials (RCTs) provide the most reliable form of scientific evidence, they are challenging to complete because of a variety of enrollment obstacles. We evaluated obstacles in a large RCT by comparing survey results at high-performing sites (HPS) and low-performing sites (LPS). METHODS: The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is a prospective, pragmatic, multicenter, and multispecialty RCT that will compare clinical outcomes, quality of life, and cost in patients with CLI randomized to surgical bypass or endovascular therapy. BEST-CLI aims to enroll 2100 patients at 160 sites in North America, Europe, and New Zealand. We surveyed the 30 HPS and 30 LPS to assess perceptions of enrollment obstacles. HPS were defined by enrollment of 0.5 subjects or more per month or more than 8 total subjects enrolled. LPS were defined by enrollment of 0.1 subjects per month or only 1 subject total. Responses were compared by site performance status. RESULTS: There were 22 of 30 (73%) HPS and 14 of 30 (47%) LPS that answered the survey (P = 0.06), including 17 investigators and 31 coordinators. The mean total enrollment and rate of enrollment at HPS and LPS were 12.5 subjects at 1.5 subjects/month and 1.0 subject at 0.1 subjects/month, respectively. The most common barrier to enrollment at HPS was difficulty convincing patients and their families to participate (36%), whereas at LPS both difficulty convincing patients and difficulty motivating investigators to enroll (29% each) were most frequently cited. At HPS, the most common obstacle to consenting patients for the trial was patient/family having strong preference toward revascularization strategy (32%) and at LPS it was patient/family not wanting to have treatment chosen at random (36%). At 55% of HPS and 43% of LPS, the trial team was reported as extremely collaborative (P = 0.73), whereas 68% of HPS and 64% of LPS reported having identified a trial champion on their team (P = 1). The most restrictive perceived enrollment criterion at HPS was prior index limb stenting with significant restenosis (32%), whereas at LPS it was excessive risk for surgical bypass (43%). Materials to aid enrollment were used equally at HPS and LPS: patient brochures at 59% HPS and 64% LPS (P = 1); investigator talking points at 45% of HPS and 36% of LPS (P = 0.73). CONCLUSIONS: Patient perceptions and investigator biases are significant challenges to enrollment in large RCTs. In the BEST-CLI trial, difficulty convincing patients and families to allow treatment randomization and difficulty in motivating investigators were major enrollment obstacles.


Assuntos
Procedimentos Endovasculares , Isquemia/cirurgia , Seleção de Pacientes , Doença Arterial Periférica/cirurgia , Tamanho da Amostra , Enxerto Vascular , Atitude do Pessoal de Saúde , Estado Terminal , Procedimentos Endovasculares/efeitos adversos , Europa (Continente) , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Isquemia/diagnóstico , Isquemia/fisiopatologia , Motivação , Nova Zelândia , América do Norte , Aceitação pelo Paciente de Cuidados de Saúde , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Estudos Prospectivos , Pesquisadores/psicologia , Sujeitos da Pesquisa/psicologia , Fatores de Tempo , Resultado do Tratamento , Enxerto Vascular/efeitos adversos
16.
Rev Med Chil ; 147(8): 1029-1035, 2019 Aug.
Artigo em Espanhol | MEDLINE | ID: mdl-31859968

RESUMO

Exceptions or waivers to informed consent in research in Chile are an ethical issue that has not been addressed in all its complexity by the scientific community. The possible waivers to this process could make the difference for the feasibility, success or failure of a study. The purpose of this document is to clarify within the available information, what is the current situation about the exceptions to informed consent in research and what are the ethical-legal guidelines in Chile. Articles were reviewed in both English and Spanish from indexed journals and those documents that meet the inclusion criteria were selected. There is limited information available about waivers to informed consent, which indicates that the ethical guidelines are similar among countries that honor the Declaration of Helsinki, including Chile. However, the current Chilean legislation does not include exceptions. Ethics Committees that authorize research in line with international ethical guidelines could allow possible exceptions. Based on our findings, it is necessary to evaluate possible exceptions for informed consent for research performed in Chile, both from the legal point of view and based on the experience of scientists.


Assuntos
Ética em Pesquisa , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Sujeitos da Pesquisa , Chile , Humanos
19.
BMJ Support Palliat Care ; 9(4): 451-463, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31719051

RESUMO

OBJECTIVES: Inclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials. METHODS: All RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.Quality of PRO reporting was evaluated using the International Society for Quality of Life Research-PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting. RESULTS: Of 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers. CONCLUSIONS: Our review indicates not only that PRO-RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal.


Assuntos
Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Sujeitos da Pesquisa , Idoso , Humanos , Resultado do Tratamento
20.
BMC Public Health ; 19(1): 1487, 2019 Nov 08.
Artigo em Inglês | MEDLINE | ID: mdl-31703655

RESUMO

BACKGROUND: Healthcare services are being increasingly digitalised in European countries. However, in studies evaluating digital health technology, some people are less likely to participate than others, e.g. those who are older, those with a lower level of education and those with poorer digital skills. Such non-participation in research - deriving from the processes of non-recruitment of targeted individuals and self-selection - can be a driver of old-age exclusion from new digital health technologies. We aim to introduce, discuss and test an instrument to measure non-participation in digital health studies, in particular, the process of self-selection. METHODS: Based on a review of the relevant literature, we designed an instrument - the NPART survey questionnaire - for the analysis of self-selection, covering five thematic areas: socioeconomic factors, self-rated health and subjective overall quality of life, social participation, time resources, and digital skills and use of technology. The instrument was piloted on 70 older study persons in Sweden, approached during the recruitment process for a trial study. RESULTS: Results indicated that participants, as compared to decliners, were on average slightly younger and more educated, and reported better memory, higher social participation, and higher familiarity with and greater use of digital technologies. Overall, the survey questionnaire was able to discriminate between participants and decliners on the key aspects investigated, along the lines of the relevant literature. CONCLUSIONS: The NPART survey questionnaire can be applied to characterise non-participation in digital health research, in particular, the process of self-selection. It helps to identify underrepresented groups and their needs. Data generated from such an investigation, combined with hospital registry data on non-recruitment, allows for the implementation of improved sampling strategies, e.g. focused recruitment of underrepresented groups, and for the post hoc adjustment of results generated from biased samples, e.g. weighting procedures.


Assuntos
Participação da Comunidade/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde/estatística & dados numéricos , Sujeitos da Pesquisa/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Participação da Comunidade/psicologia , Metodologias Computacionais , Feminino , Humanos , Masculino , Qualidade de Vida , Sujeitos da Pesquisa/psicologia , Participação Social , Fatores Socioeconômicos , Inquéritos e Questionários , Suécia
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