RESUMO
STUDY OBJECTIVE: It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting. METHODS: A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ2, and Fisher's exact tests were conducted. RESULTS: Of 317 patients and surrogates, 90% agreed with or were neutral about the statement "I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study," whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation. CONCLUSION: This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.
Assuntos
Emergências , Consentimento Livre e Esclarecido , Participação do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Adolescente , Adulto , Criança , Feminino , Humanos , Masculino , Projetos de Pesquisa , Inquéritos e Questionários , Adulto JovemRESUMO
BACKGROUND: Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. METHODS: Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. RESULTS: Clinical data from Progesterone for the Treatment of Traumatic Brain Injury trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views. CONCLUSION: Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.
Assuntos
Atitude Frente a Saúde , Pesquisa Biomédica , Lesões Encefálicas Traumáticas/tratamento farmacológico , Emergências , Consentimento Livre e Esclarecido , Progesterona/uso terapêutico , Progestinas/uso terapêutico , Ensaios Clínicos Fase III como Assunto , Escala de Coma de Glasgow , Escala de Resultado de Glasgow , Humanos , Escala de Gravidade do Ferimento , Estudos Multicêntricos como Assunto , Procurador , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
OBJECTIVE: Research in acute illness often requires an exception from informed consent. Few studies have assessed the views of patients enrolled in exception from informed consent trials. This study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury. DESIGN: Interactive interview study. SETTING: Nested within the Progesterone for the Treatment of Traumatic Brain Injury trial, a Phase III randomized controlled trial in acute traumatic brain injury. SUBJECTS: Patients and surrogates (for patients incapable of being interviewed) enrolled in Progesterone for the Treatment of Traumatic Brain Injury under exception from informed consent at 12 sites. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Interviews focused on respondents' acceptance of exception from informed consent enrollment in Progesterone for the Treatment of Traumatic Brain Injury, use of placebo and randomization, understanding of major study elements, and views regarding regulatory protections. Descriptive statistical analysis was performed; textual data were analyzed thematically. Eighty-five individuals were interviewed. Eighty-four percent had positive attitudes toward Progesterone for the Treatment of Traumatic Brain Injury inclusion. Seventy-eight percent found their inclusion under exception from informed consent acceptable, and 72% found use of exception from informed consent in Progesterone for the Treatment of Traumatic Brain Injury acceptable in general. Only two respondents clearly disagreed with both personal and general exception from informed consent enrollment. The most common concerns (26%) related to absence of consent. Eighty percent and 92% were accepting of placebo use and randomization, respectively. Although there were few black respondents (n = 11), they were less accepting of personal exception from informed consent enrollment than white respondents (55% vs 83%; p = 0.0494). CONCLUSIONS: Acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants. Exception from informed consent enrollment appears generally consistent with patients' preferences.
Assuntos
Pesquisa Biomédica/métodos , Lesões Encefálicas/tratamento farmacológico , Emergências , Consentimento Livre e Esclarecido/psicologia , Pacientes/psicologia , Progesterona/uso terapêutico , Adulto , Idoso , Feminino , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Percepção , Placebos , Grupos Raciais , Sujeitos da Pesquisa/psicologia , Fatores Sexuais , Fatores SocioeconômicosRESUMO
Background Informed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate. Methods and Results We conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P-CARE (Patient-Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient-centered interviews. In-depth interviews used open-ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study. Conclusions Barriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow-up.
Assuntos
Pesquisa Biomédica , Comunicação , Tomada de Decisões , Consentimento Livre e Esclarecido , Infarto do Miocárdio/terapia , Seleção de Pacientes , Acidente Vascular Cerebral/terapia , Adulto , Filhos Adultos , Idoso , Idoso de 80 Anos ou mais , Feminino , Pesquisa sobre Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Profissionalismo , Procurador , Pesquisa Qualitativa , Pesquisadores , Respeito , Medição de Risco , Irmãos , CônjugesRESUMO
Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients' and surrogates' experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context-sensitive approaches to consent is important.
Assuntos
Tomada de Decisões , Emergências , Consentimento Livre e Esclarecido , Entrevistas como Assunto , Infarto do Miocárdio/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Acidente Vascular Cerebral/terapia , Estudos Transversais , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
OBJECTIVE: Pretrial community consultation (CC) is required for emergency research conducted under an exception from informed consent (EFIC) in the United States. CC remains controversial and challenging, and minimal data exist regarding the views of individuals enrolled in EFIC trials on this process. It is important to know whether participants perceive CC to be meaningful and, if so, whom they believe should be consulted. METHODS: We conducted a secondary analysis of data from two studies interviewing patients and surrogates of two recent EFIC trials (PEER-RAMPART and PEER-ProTECT). These interviews included similar open- and closed-ended questions regarding participants' views of the importance of CC, the rationale for their responses, and their views regarding which populations should be included in consultation efforts. A template analytic strategy was used for qualitative analysis of textual data, and descriptive statistics were tabulated to characterize demographic data and instances of major themes. RESULTS: Ninety percent of participants perceived CC to be valuable. Participants' reasons for finding CC valuable clustered in two categories: 1) as a method of informing the public about the trial to be conducted and 2) as a way of obtaining input and feedback from the community. Participants cited the medical community (43%) and individuals with a connection to the study condition (41%) as the most important groups to involve in consultation efforts; only 5% suggested consulting the general public in the area where the research will be conducted. CONCLUSION: Participants in EFIC trials and their decision makers generally valued CC as a method of informing and seeking input from the community. Participants felt that the most appropriate groups to consult were the medical community and individuals with connections to the condition under study. Consultation efforts focused on these two groups, rather than the general public, may be more efficient and more meaningful to individuals involved in EFIC trials. These findings also reinforce the importance of the distinction between public disclosure and CC.
Assuntos
Pesquisa Biomédica , Pesquisa Participativa Baseada na Comunidade , Medicina de Emergência , Encaminhamento e Consulta , Adulto , Idoso , Idoso de 80 Anos ou mais , Relações Comunidade-Instituição , Feminino , Humanos , Consentimento Livre e Esclarecido , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
BACKGROUND: Community consultation (CC) is required for research in emergency settings using an exception from informed consent (EFIC) in the United States, but uncertainty persists regarding best CC practices. There is ongoing debate about whom to include in CC, specifically, whether to prioritize geographically defined communities or individuals with connections to the condition. Understanding the impact of personal disease experience on views of EFIC research is important for designing CC and interpreting its results. METHODS: This study was a secondary analysis of surveys administered to 2612 participants at 12 sites in CC events conducted for ProTECT III: Progesterone for Traumatic Brain Injury, a Phase III, randomized trial conducted using EFIC. Key survey domains included personal traumatic brain injury (TBI) experience, demographic information, and acceptance of both hypothetical personal enrollment under EFIC and the use of EFIC in general in ProTECT III. Descriptive statistics and multivariable regression models were used to explore relationships between key domains. RESULTS: TBI patients, those with family members/loved ones with TBI, and those who knew someone else with TBI were slightly more accepting of hypothetical personal enrollment under EFIC (adjusted odds ratio [OR] 1.14 [0.78-1.67], 1.54 [1.17-2.02], and 1.51 [1.19-1.92], respectively) and use of EFIC in general (adjusted OR 1.17 [0.83-1.64], 1.39 [1.08-1.77], and 1.06 [0.86-1.31], respectively) than those without this. In a subgroup analysis based on race, white participants with any disease experience had higher levels of acceptance of EFIC, as expected. However, there was numerically lower acceptance of personal and general EFIC enrollment among black participants with closer TBI connections. CONCLUSIONS: Personal TBI experience was associated with increased acceptance of EFIC research for that condition, except among black participants. Heterogeneity of the effect of personal disease experience on EFIC views further supports inclusion of individuals with relevant disease experience in CC and highlights the importance of engaging minority participants.
Assuntos
Atitude , Pesquisa Biomédica , Participação da Comunidade , Emergências , Consentimento Livre e Esclarecido , Sujeitos da Pesquisa , Adolescente , Adulto , Negro ou Afro-Americano , Idoso , Idoso de 80 Anos ou mais , Pesquisa Biomédica/ética , Lesões Encefálicas Traumáticas/tratamento farmacológico , Ética em Pesquisa , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Progesterona/uso terapêutico , Encaminhamento e Consulta , Estados Unidos , População Branca , Adulto JovemRESUMO
OBJECTIVE: The goal of this study was to improve understanding of patients' perspectives of informed consent for clinical trial enrollment during ST-elevation myocardial infarction (STEMI). BACKGROUND: STEMI research poses challenges regarding informed consent due to time constraints, symptom severity, and potential cognitive impairment. METHODS: An interview study was embedded within a clinical trial of an ischemic post-conditioning procedure for STEMI. An interactive, structured interview guide was used. RESULTS: Twenty interviews were conducted (median 1.5 days after initial procedure). Only 11/20 (55%) initially remembered being asked to participate in a trial. Comprehension of study details and the research process was limited; for example, many patients believed their decision was primarily clinical or that the study intervention was clearly superior. Patients described limitations regarding their ability to make a decision, including pain, discomfort, lack of time, and stress. However, patients generally felt they were able to make a decision at presentation and wanted to be the primary decision maker; few supported surrogate decision-making by family or physicians. CONCLUSIONS: This study demonstrates that patients recognize barriers to understanding but value elements of consent. Further research is needed to develop approaches that meet patients' goals while recognizing the limitations inherent to this context.
Assuntos
Compreensão , Consentimento Livre e Esclarecido/psicologia , Rememoração Mental , Infarto do Miocárdio , Sujeitos da Pesquisa/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Atitude , Tomada de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Projetos PilotoRESUMO
In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent-related questions arising when a potential surrogate decision-maker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC.