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2.
Artigo em Inglês | MEDLINE | ID: mdl-31570382

RESUMO

Informed consent, the process of gathering autonomous authorization for a medical intervention or medical research participation, is a fundamental component of medical practice. Medical informed consent assumes decision-making capacity, voluntariness, comprehension, and adequate information. The increasing use of genetic testing, particularly genomic sequencing, in clinical and research settings has presented many new challenges for clinicians and researchers when obtaining informed consent. Many of these challenges revolve around the need for patient comprehension of sufficient information. Genomic sequencing is complex-all of the possible results are too numerous to explain, and many of the risks and benefits remain unknown. Thus, historical standards of consent are difficult to apply. Alternative models of consent have been proposed to increase patient understanding, and several have empirically demonstrated effectiveness. However, there is still a striking lack of consensus in the genetics community about what constitutes informed consent in the context of genomic sequencing. Multiple approaches are needed to address this challenge, including consensus building around standards, targeted use of genetic counselors in nongenetics clinics in which genomic testing is ordered, and the development and testing of alternative models for obtaining informed consent.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31216626

RESUMO

Precision mental health (MH) holds great potential for revolutionizing MH care and reducing the burden of mental illness. Efforts to engage Asian Americans in precision MH research is necessary to help reduce MH disparities. Korean drama ("K-drama") television shows may be an effective educational tool to increase precision MH knowledge, attitudes, and behaviors (KAB) among Asian Americans. This study determined whether KAB improved after participating in a K-drama precision MH workshop, and examined the participants' perspectives about K-dramas' utility as an educational tool. A K-drama precision MH workshop in English/Vietnamese/Korean was conducted with a convenience sample (n = 122). Pre-/post-tests on precision MH KAB (genetics and genetic testing, and MH and help-seeking) and a survey on K-dramas' utility as an educational tool were administered. Findings revealed a significant difference in the pre- and post-test KAB scores overall, by genetics and genetic testing, and by MH and help-seeking. There were also significant increases in the overall post-test KAB scores by workshop (language) participation. Overall, participants responded positively on the utility of K-dramas as a precision MH educational tool. This study demonstrates the feasibility of K-drama as an innovative and widely available health education tool to educate communities about precision MH.


Assuntos
Drama , Educação em Saúde , Saúde Mental , Televisão , Adulto , Idoso , Americanos Asiáticos , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Transtornos Mentais , Pessoa de Meia-Idade , Projetos Piloto , República da Coreia , Inquéritos e Questionários
4.
Sci Data ; 6(1): 24, 2019 04 11.
Artigo em Inglês | MEDLINE | ID: mdl-30975992

RESUMO

Studies have established the importance of physical activity and fitness for long-term cardiovascular health, yet limited data exist on the association between objective, real-world large-scale physical activity patterns, fitness, sleep, and cardiovascular health primarily due to difficulties in collecting such datasets. We present data from the MyHeart Counts Cardiovascular Health Study, wherein participants contributed data via an iPhone application built using Apple's ResearchKit framework and consented to make this data available freely for further research applications. In this smartphone-based study of cardiovascular health, participants recorded daily physical activity, completed health questionnaires, and performed a 6-minute walk fitness test. Data from English-speaking participants aged 18 years or older with a US-registered iPhone who agreed to share their data broadly and who enrolled between the study's launch and the time of the data freeze for this data release (March 10 2015-October 28 2015) are now available for further research. It is anticipated that releasing this large-scale collection of real-world physical activity, fitness, sleep, and cardiovascular health data will enable the research community to work collaboratively towards improving our understanding of the relationship between cardiovascular indicators, lifestyle, and overall health, as well as inform mobile health research best practices.


Assuntos
Sistema Cardiovascular , Exercício , Sono , Adulto , Glicemia/análise , Pressão Sanguínea , Sistema Cardiovascular/metabolismo , Sistema Cardiovascular/fisiopatologia , Humanos , Smartphone , Inquéritos e Questionários , Telemedicina
5.
Genet Med ; 21(1): 107-113, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29887604

RESUMO

PURPOSE: To determine whether patients distinguish between biospecimens and electronic health records (EHRs) when considering research participation to inform research protections. METHODS: We conducted 20 focus groups with individuals who identified as African American, Hispanic, Chinese, South Asian, and non-Hispanic white on the collection of biospecimens and EHR data for research. RESULTS: Our study found that many participants did not distinguish between biospecimens and EHR data. However, some participants identified specific concerns about biospecimens. These included the need for special care and respect for biospecimens due to enduring connections between the body and identity; the potential for unacceptable future research, specifically the prospect of human cloning; heightened privacy risks; and the potential for unjust corporate profiteering. Among those who distinguished biospecimens from EHR data, many supported separate consent processes and would limit their own participation to EHR data. CONCLUSION: Considering that the potential misuse of EHR data is as great as, if not greater than, for biospecimens, more research is needed to understand how attitudes differ between biospecimens and EHR data across diverse populations. Such research should explore mechanisms beyond consent that can address diverse values, perspectives, and misconceptions about sources of patient information to build trust in research relationships.


Assuntos
Bancos de Espécimes Biológicos/ética , Pesquisa Biomédica/tendências , Registros Eletrônicos de Saúde/ética , Medicina de Precisão/ética , Pesquisa Biomédica/ética , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Disseminação de Informação , Privacidade , Pesquisadores , Inquéritos e Questionários
6.
Genet Med ; 21(3): 727-735, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-29976988

RESUMO

PURPOSE: In response to genetic testing being widely ordered by nongenetics clinicians, the Consent and Disclosure Recommendations (CADRe) Workgroup of the Clinical Genome Resource (ClinGen; clinicalgenome.org ) developed guidance to facilitate communication about genetic testing and efficiently improve the patient experience. Considering ethical, legal, and social implications, and medical factors, CADRe developed and pilot tested two rubrics addressing consent for genetic testing and results disclosure. The CADRe rubrics allow for adjusting the communication approach based on circumstances specific to patients and ordering clinicians. METHODS: We present results of a formative survey of 66 genetics clinicians to assess the consent rubric for nine genes (MLH1, CDH1, TP53, GJB2, OTC; DMD, HTT, and CYP2C9/VKORC1). We also conducted interviews and focus groups with family and patient stakeholders (N = 18), nongenetics specialists (N = 27), and genetics clinicians (N = 32) on both rubrics. RESULTS: Formative evaluation of the CADRe rubrics suggests key factors on which to make decisions about consent and disclosure discussions for a "typical" patient. CONCLUSION: We propose that the CADRe rubrics include the primary issues necessary to guide communication recommendations, and are ready for pilot testing by nongenetics clinicians. Consultation with genetics clinicians can be targeted toward more complex or intensive consent and disclosure counseling.


Assuntos
Revelação/ética , Aconselhamento Genético/métodos , Pessoal de Saúde/educação , Adulto , Competência Clínica , Comunicação , Confidencialidade , Tomada de Decisões/ética , Feminino , Aconselhamento Genético/normas , Testes Genéticos/ética , Genética/educação , Humanos , Consentimento Livre e Esclarecido/normas , Linguagem , Masculino , Estudantes
7.
Am J Bioeth ; 18(4): 3-20, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29621457

RESUMO

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: (1) Address the role of history and experience on trust, (2) engage concerns about potential group harm, (3) address cultural values and communication barriers, and (4) integrate patient values and expectations into oversight and governance structures.


Assuntos
Bancos de Espécimes Biológicos , Pesquisa Biomédica , Relações Comunidade-Instituição , Coleta de Dados , Seleção de Pacientes , Medicina de Precisão , Confiança , Pesquisa Biomédica/ética , Comunicação , Grupos de Populações Continentais , Ética em Pesquisa , Grupos Étnicos , Grupos Focais , Pesquisa em Genética , Humanos , Consentimento Livre e Esclarecido , Participação do Paciente , Pesquisadores , Características de Residência , Respeito
10.
Am J Bioeth ; 18(1): 39-45, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29313771

RESUMO

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.


Assuntos
Pesquisa Biomédica/ética , Consultoria Ética , Comitês de Ética em Pesquisa , Consentimento Livre e Esclarecido , Sujeitos da Pesquisa , Estados Unidos
12.
Artigo em Inglês | MEDLINE | ID: mdl-31211249

RESUMO

Digital phenotyping uses smartphone and wearable signals to measure cognition, mood, and behavior. This promising new approach has been developed as an objective, passive assessment tool for the diagnosis and treatment of mental illness. Digital phenotyping is currently used with informed consent in research studies but is expected to expand to broader uses in healthcare and direct-to-consumer applications. Digital phenotyping could involve the collection of massive amounts of individual data and potential creation of new categories of health and risk assessment data. Because existing ethical and regulatory frameworks for the provision of mental healthcare do not clearly apply to digital phenotyping, it is critical to consider its possible ethical, legal, and social implications. This paper addresses four major areas where guidelines and best practices will be helpful: transparency, informed consent, privacy, and accountability. It will be important to consider these issues early in the development of this new approach so that its promise is not limited by harmful effects or unintended consequences.

16.
IRB ; 39(4): 10-16, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-30387977

RESUMO

Understanding how patients decide whether to enroll in research can help improve educational materials, protocols, and recruitment rates. However, little is known about patients' willingness to participate in research on medical practices (ROMP), or studies comparing interventions within usual care. We assessed willingness to consider participating in ROMP by surveying 1095 adults in the United States, of whom 834 answered at least one open-ended question about their reasons for being willing or unwilling to consider participating in two scenarios involving ROMP. Most respondents were willing to consider participating in the research scenarios. The most commonly cited reasons for being willing to consider participating included benefit to others and oneself; the top reasons for being unwilling to consider participating included belief that the research was unsafe and an unfavorable view of experimentation. Responses also revealed misconceptions about ROMP among both those who were willing and unwilling to consider participating. Because these misconceptions may present an obstacle to recruiting participants in ROMP, there may be a need for educational initiatives to clarify the nature of these types of studies.


Assuntos
Consentimento Livre e Esclarecido , Participação do Paciente , Pesquisa , Adulto , Humanos , Inquéritos e Questionários , Estados Unidos
17.
Clin Trials ; 14(1): 94-102, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27625314

RESUMO

BACKGROUND/AIMS: Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. METHODS: We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. RESULTS: There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without. CONCLUSION: Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.


Assuntos
Pesquisa Biomédica , Conhecimentos, Atitudes e Prática em Saúde , Consentimento Livre e Esclarecido , Multimídia , Educação de Pacientes como Assunto/métodos , Adulto , Pesquisa Comparativa da Efetividade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Pragmáticos como Assunto , Inquéritos e Questionários , Gravação em Vídeo
18.
JAMA Cardiol ; 2(1): 67-76, 2017 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-27973671

RESUMO

Importance: Studies have established the importance of physical activity and fitness, yet limited data exist on the associations between objective, real-world physical activity patterns, fitness, sleep, and cardiovascular health. Objectives: To assess the feasibility of obtaining measures of physical activity, fitness, and sleep from smartphones and to gain insights into activity patterns associated with life satisfaction and self-reported disease. Design, Setting, and Participants: The MyHeart Counts smartphone app was made available in March 2015, and prospective participants downloaded the free app between March and October 2015. In this smartphone-based study of cardiovascular health, participants recorded physical activity, filled out health questionnaires, and completed a 6-minute walk test. The app was available to download within the United States. Main Outcomes and Measures: The feasibility of consent and data collection entirely on a smartphone, the use of machine learning to cluster participants, and the associations between activity patterns, life satisfaction, and self-reported disease. Results: From the launch to the time of the data freeze for this study (March to October 2015), the number of individuals (self-selected) who consented to participate was 48 968, representing all 50 states and the District of Columbia. Their median age was 36 years (interquartile range, 27-50 years), and 82.2% (30 338 male, 6556 female, 10 other, and 3115 unknown) were male. In total, 40 017 (81.7% of those who consented) uploaded data. Among those who consented, 20 345 individuals (41.5%) completed 4 of the 7 days of motion data collection, and 4552 individuals (9.3%) completed all 7 days. Among those who consented, 40 017 (81.7%) filled out some portion of the questionnaires, and 4990 (10.2%) completed the 6-minute walk test, made available only at the end of 7 days. The Heart Age Questionnaire, also available after 7 days, required entering lipid values and age 40 to 79 years (among 17 245 individuals, 43.1% of participants). Consequently, 1334 (2.7%) of those who consented completed all fields needed to compute heart age and a 10-year risk score. Physical activity was detected for a mean (SD) of 14.5% (8.0%) of individuals' total recorded time. Physical activity patterns were identified by cluster analysis. A pattern of lower overall activity but more frequent transitions between active and inactive states was associated with equivalent self-reported cardiovascular disease as a pattern of higher overall activity with fewer transitions. Individuals' perception of their activity and risk bore little relation to sensor-estimated activity or calculated cardiovascular risk. Conclusions and Relevance: A smartphone-based study of cardiovascular health is feasible, and improvements in participant diversity and engagement will maximize yield from consented participants. Large-scale, real-world assessment of physical activity, fitness, and sleep using mobile devices may be a useful addition to future population health studies.


Assuntos
Fenômenos Fisiológicos Cardiovasculares , Exercício/fisiologia , Aplicativos Móveis , Telemedicina/instrumentação , Adulto , Idoso , Aptidão Cardiorrespiratória/fisiologia , Estudos de Viabilidade , Feminino , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sono , Inquéritos e Questionários
19.
AJOB Empir Bioeth ; 7(2): 125-134, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27917391

RESUMO

BACKGROUND: Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. METHODS: We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. RESULTS: Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship. CONCLUSIONS: Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.


Assuntos
Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa , Grupos Focais , Consentimento Livre e Esclarecido/ética , Melhoria de Qualidade/ética , Sujeitos da Pesquisa , Adulto , Idoso , Atitude do Pessoal de Saúde , Assistência à Saúde , Prática Clínica Baseada em Evidências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Distribuição Aleatória , Incerteza , Estados Unidos/epidemiologia
20.
Clin Trials ; 13(5): 555-65, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27257125

RESUMO

BACKGROUND/AIMS: In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards' interpretations and applications of research regulations align with patients' values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of institutional review board professionals and one of patients, which examine views on consent for research on medical practices. METHODS: We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research membership list (40.1% response rate), limiting analysis to 537 respondents who reported having had institutional review board experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts. RESULTS: A majority of institutional review board professionals distinguished between consent preferences for medical record review and randomization, ranked clinicians as the least preferred person to obtain participant consent (54.6%), and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review, most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%), and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias. CONCLUSION: Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as institutional review boards increasingly apply research regulations in the context of research on medical practices. Dialogue between institutional review boards and research participants will be an important part of this process and should inform future regulatory guidance.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Comparativa da Efetividade/ética , Pesquisa Comparativa da Efetividade/métodos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/psicologia , Participação do Paciente/psicologia , Médicos/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Comitês de Ética em Pesquisa , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos de Pesquisa , Inquéritos e Questionários , Estados Unidos
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