Using examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied.
We assessed the reliability of epidemiological data obtained by interview of 120 patients in a case-control study. The collected data, which were obtained by interview on two separate occasions, included such clinical and pharmaceutical features as history of lactation, hysterectomy, diabetes, type of menopause, and whether a woman had ever used exogenous oestrogens. Although we found generally high rates of agreement between interviews, errors in collecting and classifying data did occur, and were especially common for complicated clinical events, such as whether an oophorectomy accompanied the surgical removal of the uterus. Patients were also likely to disagree with previous responses when asked to recall a drug exposure occurring many years before. We identified seven sources of this variability, five in collecting the data, and two in coding. As a result of these findings, strategies are proposed for improving the quality of interview data obtained in epidemiological research.
Divorce is increasingly common around the world. Its causes, dynamics, and socioeconomic impacts have been widely studied, but little research has addressed its environmental impacts. We found that average household size (number of people in a household) in divorced households (households with divorced heads) was 27-41% smaller than married households ( energy ͉ household ͉ land ͉ sustainability ͉ water
This article presents a case study of an exercise in Aboriginal community governance in Australia. It sets out the background events that led the Yawuru Native Title Holders Aboriginal Corporation in the town of Broome on Australia’s northwest coast to secure information for its own needs as an act of self-determination and essential governance, and it presents some of the key findings from that exercise. As the Indigenous rights agenda shifts from the pursuit of restitution to the management and implementation of benefits, those with proprietary rights are finding it increasingly necessary to build internal capacity for post-native title governance and community planning, including in the area of information retrieval and application. As an incorporated land-holding group, the Yawuru people of Broome are amongst the first in Australia to move in this area of information gathering, certainly in terms of the degree of local control, participation, and conceptual thinking around the logistics and rationale for such an exercise. An innovative addition has been the incorporation of survey output data into a Geographic Information System to provide for spatial analysis and a decision support mechanism for local community planning. In launching and administering the "Knowing our Community" household survey in Broome, the Yawuru have set a precedent in the acquisition and application of demographic information for internal planning and community development in the post-native title determination era.
The overall transmission rate was relatively low, suggesting effectiveness of antiretroviral transmission prophylaxis. The infant feeding choices made may reflect knowledge gained through the educational program and infant feeding counseling provided. Ensuring HIV-1-infected women receive appropriate HIV-1 treatment (for those who meet criteria for treatment) and access to known efficacious interventions to prevent mother-to-child transmission of HIV-1, are essential.
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