ObjectiveTo estimate the proportion of participants in clinical trials who understand different components of informed consent.MethodsRelevant studies were identified by a systematic review of PubMed, Scopus and Google Scholar and by manually reviewing reference lists for publications up to October 2013. A meta-analysis of study results was performed using a random-effects model to take account of heterogeneity.FindingsThe analysis included 103 studies evaluating 135 cohorts of participants. The pooled proportion of participants who understood components of informed consent was 75.8% for freedom to withdraw at any time, 74.7% for the nature of study, 74.7% for the voluntary nature of participation, 74.0% for potential benefits, 69.6% for the study’s purpose, 67.0% for potential risks and side-effects, 66.2% for confidentiality, 64.1% for the availability of alternative treatment if withdrawn, 62.9% for knowing that treatments were being compared, 53.3% for placebo and 52.1% for randomization. Most participants, 62.4%, had no therapeutic misconceptions and 54.9% could name at least one risk. Subgroup and meta-regression analyses identified covariates, such as age, educational level, critical illness, the study phase and location, that significantly affected understanding and indicated that the proportion of participants who understood informed consent had not increased over 30 years.ConclusionThe proportion of participants in clinical trials who understood different components of informed consent varied from 52.1% to 75.8%. Investigators could do more to help participants achieve a complete understanding.
In 2006, typhoon Xangsane disrupted a multi-agency health needs study of 4,982 individuals in Vietnam. Following this disaster, 798 of the original participants were re-interviewed to determine NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript prevalence and risk-factors associated with post-traumatic stress disorder (PTSD), major depressive disorder (MDD), panic disorder (PD), and generalized anxiety disorder (GAD) according to the DSM-IV (APA, 1994). Post-typhoon prevalences were: PTSD 2.6%; MDD 5.9%; PD 9.3%; GAD 2.2%. Of those meeting criteria for a disorder, 70% reported only one disorder, 15% had two, 14% had three, and 1% met criteria for all four disorders. Risk factors for post-typhoon psychopathology differed among disorders, but generally were related to high typhoon exposure, prior trauma exposure, and in contrast to Western populations, higher age, but not gender. Keywords DISASTER; TYPHOON; PTSD; DEPRESSION; PANIC; VIETNAMHurricanes striking the coast of the United States significantly affected both physical infrastructure and health in the past five years, and questions have been raised regarding the mental health effects of such events (Acierno, Ruggiero, Galea et al., 2007;Acierno, Ruggiero, Resnick et al., 2006;Galea, Brewin, Jones, et al., 2007; Kahn, Mackert & Johnson, 2007;Rhoads, Pearman, Rick, 2007;Weems, Watts, Marsee, 2007;Weisler, Barbee & Townsend, 2006). As expected, hurricane researchers replicated previous findings of increased prevalence of negative mental health outcomes secondary to other natural disasters (Briere & Elliot, 2000;Galea et al., 2007;Norris, 2005;Norris Friedman & Watson, 2002a;Norris, Friedman, Watson et al., 2002b;Sajid, 2007), including posttraumatic stress disorder [PTSD], major depressive disorder [MDD], generalized anxiety disorder [GAD], panic disorder [PD], and substance use disorders. Moreover, specific risk factors for these negative outcomes were identified, including pre-hurricane exposure to potentially traumatic events (PTEs), high fear levels during the hurricane itself, lower age, and low social support (Acierno et al., 2007).Most post-disaster research has been on Western populations, and relatively little research exists on mental health effects of disasters on diverse populations outside of the United States (Norris et al., 2002b), particularly in lower or middle income countries, with less well developed mental health infrastructures such as that in Vietnam. However, recent efforts by the Vietnamese government to conduct mental health needs analyses, specifically the Da Nang Department of Health and the Khanh Hoa Health Service serendipitously allowed us to begin to address this deficit. During one of these needs analyses, on October 26 th , 2006 typhoon Xangsane, equivalent to a Category 4 hurricane, struck Vietnam. Despite an extraordinarily successful evacuation, Xangsane was responsible for at least 72 deaths, hundreds of severe injuries, and at least $629 million in damages in Vietnam (Iglesias, 2006; Chaudh...
The increased rice production in the Mekong Delta during the last two decades has improved agricultural income and reduced poverty, but it has also had negative impacts on the environment and human health. This study shows that integrated rice–fish farming and integrated pest management strategies provide sustainable options to intensive rice farming, because of a more balanced use of multiple ecosystem services that benefit the farmers’ health, economy and the environment. The study investigates and compares farming strategies among 40 rice and 20 rice–fish farmers in two locations in the Mekong Delta. Production costs and income are used to compare the systems’ financial sustainability. The farmers’ perception on how their farming practices influence on ecosystem services and their livelihoods are used as an indication of the systems’ ecological and social sustainability. Although rice–fish farmers used lower amount of pesticides and fertilisers than rice farmers, there were no statistical differences in their rice yields or net income. Rice was seen as the most important ecosystem service from rice fields and related wetlands, but also several other ecosystem services, such as water quality, aquatic animals, plants, habitats, and natural enemies to pests, were seen as important to the farmers’ livelihoods and wellbeing. All farmers perceived that there had been a general reduction in all these other ecosystem services, due to intensive rice farming during the last 15 years, and that they will continue to decline. The majority of the farmers were willing to reduce their rice yields slightly for an improved quality of the other ecosystem services.
BackgroundCells within breast cancer stem cell populations have been confirmed to have a CD44+CD24− phenotype. Strong expression of CD44 plays a critical role in numerous types of human cancers. CD44 is involved in cell differentiation, adhesion, and metastasis of cancer cells.MethodsIn this study, we reduced CD44 expression in CD44+CD24− breast cancer stem cells and investigated their sensitivity to an antitumor drug. The CD44+CD24− breast cancer stem cells were isolated from breast tumors; CD44 expression was downregulated with siRNAs followed by treatment with different concentrations of the antitumor drug.ResultsThe proliferation of CD44 downregulated CD44+CD24− breast cancer stem cells was decreased after drug treatment. We noticed treated cells were more sensitive to doxorubicin, even at low doses, compared with the control groups.ConclusionsIt would appear that expression of CD44 is integral among the CD44+CD24− cell population. Reducing the expression level of CD44, combined with doxorubicin treatment, yields promising results for eradicating breast cancer stem cells in vitro. This study opens a new direction in treating breast cancer through gene therapy in conjunction with chemotherapy.
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