RESUMEN
BACKGROUND: South Africa (SA) has embarked on a process to implement universal health coverage (UHC) funded by National Health Insurance (NHI). The 2019 NHI Bill proposes creation of a health technology assessment (HTA) body to inform decisions about which interventions NHI funds will cover under UHC. In practice, HTA often relies mainly on economic evaluations of cost-effectiveness and budget impact, with less attention to the systematic, specific consideration of important social, organisational and ethical impacts of the health technology in question. In this context, the South African Values and Ethics for Universal Health Coverage (SAVE-UHC) research project recognised an opportunity to help shape the health priority-setting process by providing a way to take account of multiple, ethically relevant considerations that reflect SA values. The SAVE-UHC Research Team developed and tested an SA-specific Ethics Framework for HTA assessment and analysis. OBJECTIVES: To develop and test an Ethics Framework for use in the SA context for health priority-setting. METHODS: The Framework was developed iteratively by the authors and a multidisciplinary panel (18 participants) over a period of 18 months, using the principles outlined in the 2015 NHI White Paper as a starting point. The provisional Ethics Framework was then tested with multi-stakeholder simulated appraisal committees (SACs) in three provinces. The membership of each SAC roughly reflected the composition of a potential SA HTA committee. The deliberations and dedicated focus group discussions after each SAC meeting were recorded, analysed and used to refine the Framework, which was presented to the Working Group for review, comment and final approval. RESULTS: This article describes the 12 domains of the Framework. The first four (Burden of the Health Condition, Expected Health Benefits and Harms, Cost-Effectiveness Analysis, and Budget Impact) are commonly used in HTA assessments, and a further eight cover the other ethical domains. These are Equity, Respect and Dignity, Impacts on Personal Financial Situation, Forming and Maintaining Important Personal Relationships, Ease of Suffering, Impact on Safety and Security, Solidarity and Social Cohesion, and Systems Factors and Constraints. In each domain are questions and prompts to enable use of the Framework by both analysts and assessors. Issues that arose, such as weighting of the domains and the availability of SA evidence, were discussed by the SACs. CONCLUSIONS: The Ethics Framework is intended for use in priority-setting within an HTA process. The Framework was well accepted by a diverse group of stakeholders. The final version will be a useful tool not only for HTA and other priority-setting processes in SA, but also for future efforts to create HTA methods in SA and elsewhere.
Asunto(s)
Prioridades en Salud , Cobertura Universal del Seguro de Salud , Tecnología Biomédica , Humanos , Sudáfrica , Evaluación de la Tecnología BiomédicaRESUMEN
The prospect of using cell-based interventions (CBIs) to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior-brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment.
Asunto(s)
Afecto , Conducta , Trasplante de Tejido Encefálico/ética , Trasplante de Células/ética , Enfermedades del Sistema Nervioso Central/cirugía , Ensayos Clínicos como Asunto/ética , Cognición , Consentimiento Informado , Investigación Biomédica/ética , Trasplante de Tejido Encefálico/efectos adversos , Trasplante de Células/efectos adversos , Ética en Investigación , Humanos , Pruebas Neuropsicológicas , Sujetos de Investigación , Encuestas y Cuestionarios , Experimentación Humana Terapéutica/éticaRESUMEN
BACKGROUND: Attempts to translate basic stem cell research into treatments for neurologic diseases and injury are well under way. With a clinical trial for one such treatment approved and in progress in the United States, and additional proposals under review, we must begin to address the ethical issues raised by such early forays into human clinical trials for cell-based interventions for neurologic conditions. METHODS: An interdisciplinary working group composed of experts in neuroscience, cell biology, bioethics, law, and transplantation, along with leading disease researchers, was convened twice over 2 years to identify and deliberate on the scientific and ethical issues raised by the transition from preclinical to clinical research of cell-based interventions for neurologic conditions. RESULTS: While the relevant ethical issues are in many respects standard challenges of human subjects research, they are heightened in complexity by the novelty of the science, the focus on the CNS, and the political climate in which the science is proceeding. CONCLUSIONS: Distinctive challenges confronting US scientists, administrators, institutional review boards, stem cell research oversight committees, and others who will need to make decisions about work involving stem cells and their derivatives and evaluate the ethics of early human trials include evaluating the risks, safety, and benefits of these trials, determining and evaluating cell line provenance, and determining inclusion criteria, informed consent, and the ethics of conducting early human trials in the public spotlight. Further study and deliberation by stakeholders is required to move toward professional and institutional policies and practices governing this research.
Asunto(s)
Encefalopatías/terapia , Tratamiento Basado en Trasplante de Células y Tejidos/ética , Ensayos Clínicos como Asunto/ética , Neurología/ética , Neurología/normas , Animales , Investigación Biomédica/ética , Investigación Biomédica/normas , Investigación Biomédica/tendencias , Tratamiento Basado en Trasplante de Células y Tejidos/métodos , Tratamiento Basado en Trasplante de Células y Tejidos/normas , Comités de Monitoreo de Datos de Ensayos Clínicos/normas , Comités de Monitoreo de Datos de Ensayos Clínicos/tendencias , Ensayos Clínicos como Asunto/normas , Comités de Ética en Investigación/normas , Comités de Ética en Investigación/tendencias , Humanos , Neurología/tendencias , Medición de Riesgo , Trasplante de Células Madre/ética , Trasplante de Células Madre/métodos , Trasplante de Células Madre/normas , Factores de Tiempo , Estados Unidos , United States Food and Drug Administration/normas , United States Food and Drug Administration/tendenciasRESUMEN
Recently we argued that social justice is concerned with human well-being, which is best understood as involving plural, irreducible dimensions, each of which represents something of independent moral significance. Health is one of these distinct dimensions of well-being, as is personal security, the development and exercise of cognitive capacities for reasoning, living under conditions of social respect, developing and sustaining deep personal attachments, and being able to lead self-determining lives. In this paper, we address why considerations of justice, and not utilitarian aims as applied narrowly to health outcomes, are most foundational to public health. In particular, we argue that the aspiration for improvement of the health of populations defines the positive aim of justice in public health, along with the negative aim of reducing or combating systematic disadvantage that affects adversely historically situated social groups and, more generally, children across the normal life span when their well-being is not assigned a special priority in the development of public health policies.
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Estado de Salud , Salud Pública , Justicia Social , Factores Socioeconómicos , Adulto , Niño , Mortalidad del Niño , Protección a la Infancia , Preescolar , Humanos , Lactante , Esperanza de Vida , Principios Morales , Pobreza , Poblaciones VulnerablesRESUMEN
The licensure in 2006 of a vaccine against the subtypes of human papillomavirus (HPV) responsible for the majority of cervical cancers and genital warts was heralded as a watershed moment for vaccination, cancer prevention, and global health. A safe and effective vaccine against HPV has long been viewed as an enormous asset to cervical cancer prevention efforts worldwide. This is particularly true for places lacking robust Pap screening programs where cervical cancer has the greatest prevalence and mortality. Well before its licensure, however, some observers noted significant obstacles that would need to be addressed in order for an HPV vaccination program to succeed. These included the vaccine's relatively high cost, availability, and opposition from socially conservative groups. Such concerns associated with the implementation of HPV vaccination were soon overwhelmed by the furor that followed the unexpectedly early efforts by the US state governments to require the vaccine as a condition of attendance in public schools, proposals imprecisely referred to as "mandates." In this study, we review the controversy surrounding this debate and its effects on important ethical and public health issues that still need to be addressed.
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Industria Farmacéutica/ética , Programas Obligatorios/ética , Vacunación Masiva/ética , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus , Instituciones Académicas/legislación & jurisprudencia , Neoplasias del Cuello Uterino/prevención & control , Adolescente , Adulto , Niño , Costos de los Medicamentos , Femenino , Accesibilidad a los Servicios de Salud , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18 , Humanos , Maniobras Políticas , Michigan , Vacunas contra Papillomavirus/efectos adversos , Vacunas contra Papillomavirus/economía , Padres , Autonomía Personal , Política , Política Pública , Enfermedades Virales de Transmisión Sexual/prevención & control , Gobierno Estatal , Texas , Infecciones Tumorales por Virus/prevención & control , Estados Unidos , Neoplasias del Cuello Uterino/virologíaRESUMEN
BACKGROUND: People with retinitis pigmentosa (RP) experience functional and psychological challenges as they adjust to progressive loss of visual function. The authors aimed to understand better the process of adjusting to RP in light of the emotional suffering associated with this process. METHODS: Adults with RP were recruited from the Foundation Fighting Blindness and the Wilmer Eye Institute in Baltimore. Focus groups and semistructured interviews addressed the process of adjusting to RP and were audiotaped and transcribed. The transcripts were analysed qualitatively in order to generate a model of adjustment. RESULTS: A total of 43 individuals participated. It was found that, on diagnosis, people with RP seek to understand its meaning in their lives. Mastering the progressive functional implications associated with RP is contingent upon shifting personal identity from a sighted to a visually impaired person. In this sample, six participants self identified as sighted, 10 self identified as in transition, and 27 self identified as visually impaired. This adjustment process can be understood in terms of a five stage model of behaviour change. CONCLUSIONS: The proposed model presents one way to understand the process of adjusting to RP and could assist ophthalmologists in meeting their moral obligation to lessen patients' suffering, which arises in the course of their adjustment to progressive loss of visual function.
Asunto(s)
Adaptación Psicológica , Modelos Psicológicos , Retinitis Pigmentosa/complicaciones , Trastornos de la Visión/etiología , Trastornos de la Visión/psicología , Adulto , Anciano , Actitud Frente a la Salud , Progresión de la Enfermedad , Femenino , Grupos Focales , Humanos , Entrevista Psicológica , Masculino , Persona de Mediana Edad , Retinitis Pigmentosa/psicología , Autoimagen , Factores Socioeconómicos , Personas con Daño Visual/psicologíaRESUMEN
The use of aggregated quality of life estimates in the formation of public policy and practice guidelines raises concerns about the moral relevance of variability in values in preferences for health care. This variability may reflect unique and deeply held beliefs that may be lost when averaged with the preferences of other individuals. Feminist moral theories which argue for attention to context and particularity underline the importance of ascertaining the extent to which differences in preferences for health states reveal information which is morally relevant to clinicians and policymakers. To facilitate these considerations, we present an empirical study of preferences for the timing and occurrence of health states associated with hormone replacement therapy (HRT). Sixteen women between the ages of 45 and 55 were enrolled in this pilot study. Their preferences regarding five health states associated with HRT (menopausal symptoms. side effects of HRT, breast cancer, myocardial infarction, and osteoporosis) were assessed in quantitative terms known as utilities. Two standard methods, the visual analog scale (VAS) and the standard gamble (SG), were used to assess utility and time preference (calculated as a discount rate). The wide variability of responses underlines the importance of tailoring health care to individual women's preferences. Policy guidelines which incorporate utility analysis must recognize the normative limitations of aggregated preferences, and the moral relevance of individual conceptions of health.
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Terapia de Reemplazo de Estrógeno/normas , Ética Médica , Aceptación de la Atención de Salud , Análisis Costo-Beneficio , Toma de Decisiones , Femenino , Feminismo , Humanos , Menopausia , Persona de Mediana Edad , Proyectos Piloto , Estados UnidosRESUMEN
This paper describes the relationship between psychosocial factors and health related quality of life among 287 HIV-positive women using items from the Medical Outcomes Study HIV Health Survey to measure physical functioning, mental health and overall quality of life. Multivariate models tested the relative importance of sociodemographic characteristics, HIV-related factors and psychosocial variables in explaining these quality of life outcomes. A history of child sexual abuse and adult abuse, social support and health promoting self-care behaviors were the psychosocial factors studied. Women in the sample were on average 33 years old and had known they were HIV-positive for 41 months; 39% had been hospitalized at least once due to their HIV; 83% had children; 19% had a main sex partner who was also HIV-positive. More than one-half of the women (55%) had a history of injection drug use and 63% reported having been physically or sexually assaulted at least once as an adult. A history of childhood sexual abuse. reported by 41% of the sample, was significantly related to mental health after controlling for sociodemographic and HIV-related characteristics. Women with larger social support networks reported better mental health and overall quality of life. Women who practiced more self-care behaviors (healthy diet and vitamins, adequate sleep and exercise, and stress management) reported better physical and mental health and overall quality of life. The high prevalence of physical abuse and child sexual abuse reported by this sample underscores the importance of screening for domestic violence when providing services to HIV-positive women. That such potentially modifiable factors as social support and self care behaviors are strongly associated with health-related quality of life suggests a new opportunity to improve the lives of women living with HIV.
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Seropositividad para VIH/psicología , Conductas Relacionadas con la Salud , Calidad de Vida , Adolescente , Adulto , Baltimore , Femenino , Conductas Relacionadas con la Salud/etnología , Promoción de la Salud , Indicadores de Salud , Humanos , Persona de Mediana Edad , Análisis Multivariante , Calidad de Vida/psicología , Factores de Riesgo , Autocuidado , Apoyo Social , Violencia/estadística & datos numéricosRESUMEN
This paper describes the frequency of women's disclosure of their HIV status, examines the extent to which they experience adverse social and physical consequences when others learn they are infected, and analyzes correlates of these negative outcomes. There were 257 HIV-positive women between the ages of 18 and 44, recruited from HIV/AIDS primary care clinics and from community sites, who completed a face-to-face interview. Women in the sample were 33 years old on average; 92% were African-American; 54% had less than 12 years of education; 56% had used intravenous drugs; and 30% knew they were HIV positive for 5 or more years. There were 97% who disclosed their HIV status; 64% told more than 5 people. Negative consequences associated with others knowing they were HIV-positive were reported by 44%, most commonly the loss of friends (24%), being insulted or sworn at (23%), and being rejected by family (21%). There were 10 women (4%) who reported being physically or sexually assaulted as a result of their being HIV positive, and 16% reported having no one they could count on for money or a place to stay. Violence was widespread in this sample, with 62% having experienced physical or sexual violence, including sexual abuse or rape (27%), being beaten up (34%), and weapon-related violence (26%). Logistic regression analysis indicated that women with a history of physical and sexual violence were significantly more likely to experience negative social and physical consequences when their infection became known to others, adjusting for age and the number of people women had disclosed to, both of which were only marginally significant. Partner notification policies and support programs must be responsive to the potential negative consequences associated with others learning that a woman is HIV positive. The high rates of historical violence in the lives of women living with HIV underscore the need for routine screening and intervention for domestic violence in all settings that provide health care to HIV-positive women.
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Trazado de Contacto , Infecciones por VIH/psicología , Apoyo Social , Maltrato Conyugal , Revelación de la Verdad , Salud de la Mujer , Adolescente , Adulto , Baltimore/epidemiología , Femenino , Infecciones por VIH/epidemiología , Humanos , Encuestas y CuestionariosRESUMEN
Although women had been under recognized in the literature on HIV/AIDS, increasing numbers of studies have focused on the lives and experiences of women living with HIV/AIDS. Areas of research in which the study of women and HIV continues to be noticeably lacking include health related quality of life (HRQOL). This paper describes HRQOL in an inner city sample of 287 HIV positive non-pregnant women, interviewed as part of a larger multi-site CDC funded study of the reproductive health of women. The average age of the respondents was 33 years and women had known their HIV status an average of 41 months. HRQOL was assessed using a 17-item modified version of the Medical Outcomes Study-HIV Health Survey and demonstrated acceptable internal consistency (0.64-0.89) and variability. Women in our study were similar to other HIV-positive female samples and reported lower levels of well-being and functioning than some HIV-positive male samples. Women's responses to individual items and areas of potential need for health care are discussed. Examination of HRQOL in women with HIV can aid in the comparison of how women and men are affected by HIV and can help health care professionals identify needed services and include possible interventions to promote quality of life.
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Infecciones por VIH , Estado de Salud , Calidad de Vida , Encuestas y Cuestionarios , Adulto , Baltimore , Femenino , Infecciones por VIH/psicología , Planificación en Salud , Humanos , Reproducibilidad de los ResultadosAsunto(s)
Ensayos Clínicos como Asunto , Grupos Control , Países en Desarrollo , Ética Médica , Infecciones por VIH/prevención & control , Mujeres Embarazadas , Revelación , Relativismo Ético , Revisión Ética , Humanos , Consentimiento Informado , Internacionalidad , Defensa del Paciente , Proyectos de Investigación , Sujetos de Investigación , Medición de Riesgo , Justicia Social , Experimentación Humana Terapéutica , Poblaciones VulnerablesAsunto(s)
Infecciones por VIH/prevención & control , Educación en Salud/organización & administración , Conocimientos, Actitudes y Práctica en Salud , Madres/educación , Atención Prenatal/organización & administración , Servicios Urbanos de Salud/organización & administración , Adulto , Femenino , Hospitales de Enseñanza , Humanos , Madres/psicología , Evaluación de Programas y Proyectos de Salud , Encuestas y CuestionariosRESUMEN
A smoking cessation and relapse prevention intervention was tested in an urban, prenatal clinic serving predominantly low-income, African-American women. At their first prenatal visit, 391 smokers were randomly assigned to an experimental (E) group to receive usual clinic information plus a prenatal and postpartum intervention or to a control (C) group to receive only usual clinic information. The intervention consisted of individual skills instruction and counseling by a peer health counselor on the use of a self-help cessation guide and routine clinic reinforcement. Among the E group (n = 193), 6.2% were cotinine-confirmed quitters at third trimester and among the C group (n = 198) the quit rate was 5.6%. Quitters were light smokers at entry into prenatal care. Many had tried to quit smoking at least once prior to pregnancy.
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Embarazo , Atención Prenatal , Cese del Hábito de Fumar , Adulto , Instituciones de Atención Ambulatoria , Femenino , Humanos , Salud UrbanaRESUMEN
Women represent an increasing proportion of AIDS cases and anecdotal reports suggest some face substantial risks when others learn they are HIV-positive. The purpose of this paper is to describe women's fears and experiences regarding disclosure of their HIV status. Fifty HIV-positive women, ages 16-45 from urban teaching hospital outpatient clinics, were interviewed using an in-depth, qualitative interview. Eighty-six percent of the women were African American and 56% were current or former IVDU. At the time of the interview, 88% of the women had known their HIV status for a year or more. All but one woman had disclosed her HIV status to at least one person and 82% had disclosed to multiple people. Although two-thirds of the women had been afraid to disclose to others because of concerns about rejection, discrimination or violence, three-quarters of the sample reported only supportive and understanding responses to their disclosure. One-quarter of the sample reported negative consequences of disclosure, including rejection, abandonment, verbal abuse and physical assault. Disclosure-related violence was discussed by nine women (18%): two who feared violence were relieved to find a supportive response; four chose not to disclose their status because they feared violence; and three women were verbally or physically assaulted. Fear of mistreatment figured prominently in decisions about disclosure among this sample. That many women found supportive and understanding responses is encouraging. However, there were sufficient examples of negative consequences, including violence, to suggest individualized approaches to post-test counseling, enhanced support services for HIV-positive women, and public education to destigmatize HIV-disease.
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Actitud Frente a la Salud , Infecciones por VIH/diagnóstico , Infecciones por VIH/psicología , Revelación de la Verdad , Salud Urbana , Violencia , Adolescente , Adulto , Baltimore , Familia/psicología , Miedo , Femenino , Humanos , Persona de Mediana Edad , Prejuicio , Parejas Sexuales/psicología , Apoyo Social , Encuestas y CuestionariosRESUMEN
Early identification of pregnant women infected with the human immunodeficiency virus (HIV) is becoming increasingly important in light of recent findings that interventions during and shortly after pregnancy can reduce the rates of vertical transmission. The ability of patients to accurately self-report previous HIV testing and test results is important in clinical settings. Over a one-year period, 283 women attending a hospital-affiliated obstetrical clinic reported previous HIV testing (44% of the total women approached), and 105 women (37% of the women reporting previous testing) reported being previously tested at that hospital. Self-reported data on previous HIV testing at the hospital were compared with information maintained in a centralized computerized database by the hospital laboratory. Only 41.9% of the women who reported previous HIV testing at the hospital had their reports confirmed. Women whose HIV testing reports were confirmed were found to be similar to those women whose reports were not confirmed with regard to age, educational level, gestational age, parity, reason(s) for seeking HIV testing, and knowledge of testing, transmission and acquired immunodeficiency syndrome (AIDS). These data suggest that, when HIV status is of concern, health care professionals should continue to encourage testing in the absence of laboratory documentation of recent HIV antibody testing.
Asunto(s)
Infecciones por VIH/prevención & control , Seropositividad para VIH/diagnóstico , Conocimientos, Actitudes y Práctica en Salud , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Participación del Paciente , Complicaciones Infecciosas del Embarazo/diagnóstico , Mujeres Embarazadas , Adulto , Estudios de Cohortes , Revelación , Femenino , Infecciones por VIH/transmisión , Humanos , EmbarazoRESUMEN
The Advisory Committee on Human Radiation Experiments (ACHRE), established to review allegations of abuses of human subjects in federally sponsored radiation research, was charged with identifying appropriate standards to evaluate the ethics of cold war radiation experiments. One central question for ACHRE was to determine what role, if any, the Nuremberg Code played in the norms and practices of US medical researchers. Based on the evidence from ACHRE's Ethics Oral History Project and extensive archival research, we conclude that the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subjects research. Although some clinical investigators raised questions about the conduct of research involving human beings, the medical profession did not pursue this issue until the 1960s.
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Códigos de Ética , Ética Médica/historia , Experimentación Humana/historia , Traumatismos por Radiación , Radio (Elemento)/efectos adversos , Investigación/legislación & jurisprudencia , Comités Consultivos , Historia del Siglo XX , Holocausto/historia , Derechos Humanos , Humanos , Internacionalidad , Nacionalsocialismo , Personas , Sujetos de Investigación , Estados Unidos , Poblaciones VulnerablesRESUMEN
Like the National Commission and the President's Commission, the Advisory Committee on Human Radiation Experiments was formed to carry out specific ethical tasks. Yet the committee also had an "openness" mission, a charge to investigate allegations that the U.S. government secretly exposed Americans to environmental releases of radiation. Eighteen months later- and after sixteen public meetings, more than 200 interviews, and the review of about 400,000 documents-the committee delivered a 925-page report to the president.
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Comités Consultivos , Bioética , Gobierno Federal , Experimentación Humana , Comité de Profesionales , Efectos de la Radiación , Miembro de Comité , Compensación y Reparación , Revelación , Análisis Ético , Eticistas , Comités de Ética en Investigación , Gobierno , Regulación Gubernamental , Humanos , Personas , Política Pública , Sujetos de Investigación , Juicio Moral Retrospectivo , Responsabilidad Social , Confianza , Estados Unidos , Poblaciones VulnerablesRESUMEN
It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient-subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient-subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.
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Comprensión , Participación del Paciente , Relaciones Médico-Paciente , Sujetos de Investigación , Investigación , Relaciones Investigador-Sujeto , Confianza , Comités Consultivos , Ensayos Clínicos como Asunto , Formularios de Consentimiento , Revelación , Investigación Empírica , Comités de Ética en Investigación , Humanos , Motivación , Paternalismo , Medición de Riesgo , Experimentación Humana Terapéutica , Terapias en Investigación , Revelación de la VerdadRESUMEN
OBJECTIVE: To assess the effectiveness of education about cystic fibrosis carrier screening in a primary care setting. DESIGN: Participants were asked to read a brochure, and were offered cystic fibrosis carrier screening. They were assessed for knowledge after reading the brochure and again after having an opportunity to ask questions and reread the brochure at home, at which time consent for testing was obtained. SETTING: Two sites of a health maintenance organization in the Baltimore, Md, area. PARTICIPANTS: Enrollees in a health maintenance organization aged 18 to 44 years. Of 608 enrollees approached, 477 completed an initial knowledge questionnaire, and 143 consented to testing. MAIN OUTCOME MEASURE: Change in knowledge score. RESULTS: Knowledge scores improved from a mean of 69% correct initially to 75% at the time of consent (P < 0.1, Student's paired t test). When participants were stratified by educational attainment, significant improvement was observed only for participants with no more than a high school education. However, their final knowledge score was significantly lower than that of college graduates. CONCLUSIONS: For people with more formal education, printed materials augmented by a chance to ask questions may be sufficient to ensure informed consent. For less well-educated persons, additional education may be necessary to ensure understanding of difficult concepts.