Clinical Trials and Medical Care: Defining the Therapeutic Misconception

A key component of informed consent to participate in medical research includes understanding that research is not the same as treatment

Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana

Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway.We assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004-2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have ≥ 16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants' highest education levels were: 28% primary, 59% secondary, 9% tertiary and 7% no formal education. Eighty percent of participants passed the enrollment quiz (Quiz1) on their first attempt and the remainder passed on their second attempt. Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4-4.0) and 1.5 (1.2, 1.9), respectively). The trial's purpose or procedures were understood by 90-100% of participants, while 44-77% understood randomization, placebos, or risks. Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial. Pass rates improved with quiz re-administration in subsequent years.Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large, international collaboration and efficiently determined IC comprehension by trial participants. Strategies to improve understanding of concepts like placebos and randomization are needed. Comprehension assessments throughout a study may reinforce key concepts

Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine

Despite rapid technical progress and demonstrable effectiveness for some types of diagnosis and therapy, much remains to be learned about clinical genome and exome sequencing (CGES) and its role within the practice of medicine. The Clinical Sequencing Exploratory Research (CSER) consortium includes 18 extramural research projects, one National Human Genome Research Institute (NHGRI) intramural project, and a coordinating center funded by the NHGRI and National Cancer Institute. The consortium is exploring analytic and clinical validity and utility, as well as the ethical, legal, and social implications of sequencing via multidisciplinary approaches; it has thus far recruited 5,577 participants across a spectrum of symptomatic and healthy children and adults by utilizing both germline and cancer sequencing. The CSER consortium is analyzing data and creating publically available procedures and tools related to participant preferences and consent, variant classification, disclosure and management of primary and secondary findings, health outcomes, and integration with electronic health records. Future research directions will refine measures of clinical utility of CGES in both germline and somatic testing, evaluate the use of CGES for screening in healthy individuals, explore the penetrance of pathogenic variants through extensive phenotyping, reduce discordances in public databases of genes and variants, examine social and ethnic disparities in the provision of genomics services, explore regulatory issues, and estimate the value and downstream costs of sequencing. The CSER consortium has established a shared community of research sites by using diverse approaches to pursue the evidence-based development of best practices in genomic medicine

Historias rivales: narrativas locales de raza, lugar y nación en Riosucio

Benedict Anderson elaboró una famosa descripción de la nación como una comunidad imaginada. En el municipio de Riosucio, Caldas, generaciones sucesivas de habitantes locales imaginaron la comunidad al construir narrativas rivales sobre la historia local. Éstas describían al municipio surgiendo a partir de las dos plazas opuestas a la cabecera, una india y otra blanca. Este artículo analiza la elaboración de historias en competencia durante tres momentos o periodos de los siglos XIX y XX. A través de estas historias locales sobre los orígenes de una comunidad dividida, los intelectuales de la región intentaron reimaginar una Colombia dividida por la violencia como una nación unificada. Más recientemente, hemos entrado en un cuarto momento, ha surgido una versión pluricultural de identidad local y nacional, pero al igual que las primeras versiones, ésta también ha tenido oposició

Historias rivales: narrativas locales de raza, lugar y nación en Riosucio

Benedict Anderson famously described the nation as an “imagined community.” In the municipio of Riosucio, Caldas, succeeding generations of local inhabitants imagined community by elaborating rival narratives of local history. These narratives described the municipio as emerging out of the two opposing plazas of the cabecera, one “Indian” and the other “white.” This article traces the elaboration of competing histories over three “moments” or periods during the nineteenth and twentieth centuries. Through these local stories about the origins of a divided community, local intellectuals attempted to reimagine a violently divided Colombia as a unified national community. More recently, we have entered a fourth moment; a pluricultural version of local and national identity has emerged, but like the earlier versions, it too is contested.Benedict Anderson elaboró una famosa descripción de la nación como una “comunidad imaginada”. En el municipio de Riosucio, Caldas, generaciones sucesivas de habitantes locales imaginaron la comunidad al construir narrativas rivales sobre la historia local. Éstas describían al municipio surgiendo a partir de las dos plazas opuestas a la cabecera, una “india” y otra “blanca”. Este artículo analiza la elaboración de historias en competencia durante tres “momentos” o periodos de los siglos XIX y XX. A través de estas historias locales sobre los orígenes de una comunidad dividida, los intelectuales de la región intentaron reimaginar una Colombia dividida por la violencia como una nación unificada. Más recientemente, hemos entrado en un cuarto momento, ha surgido una versión pluricultural de identidad local y nacional, pero al igual que las primeras versiones, ésta también ha tenido oposición